Wednesday, 22 April 2020

International collaboration on GMP inspections

The section on International collaboration on GMP inspections has been updated in regard to manufacturers of sterile medicines. EMA and its European and international partners have launched a pilot programme to share information on GMP inspections of manufacturers of sterile medicines located outside the participating countries and to organise joint inspections of manufacturing sites of common interest.

The prerequisites for sterile products are:
  • They are sterile (in all probability, based on the control of sterility
  • assurance).
  • Pyrogen free (apyrogenic).
  • Free of visible particles

Other key quality attributes for sterile products are:
  • Chemical/biological purity.
  • Correct dose/strength – correctly labelled .
  • Correct physical form e.g. colour, particle size, viscosity.
  • No physical contaminants.

Batch release is the process of reviewing and approving all pharmaceutical product manufacturing and control records and it performed by the Quality Unit to determine compliance with all established approved written procedures before a batch is released. The process of batch release, and the authority and training of the persons eligible to do so, varies according to different GMP systems.

The products in scope include sterile medicines for human use of chemical origin and certain therapeutic biotechnology - derived products, such as monoclonal antibodies and recombinant proteins. Vaccines, cell and gene therapies and plasma derived pharmaceuticals are currently out of the scope of this pilot.

For further details, see:

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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